Metoprolol Succinate (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Metoprolol Succinate Extended-Release Tablets, USP are available containing 23.75 mg, 47.5 mg, 95 mg or 190 mg of metoprolol succinate, USP equivalent to 25 mg, 50 mg, 100 mg or 200 mg of metoprolol tartrate, USP, respectively.

25 mg tablets: White to off white, oval shape, biconvex film coated tablet with breakline on one side and debossed with ‘A’ and ‘3’ on each side of breakline on other side. They are available as follows:

67877-590-30 Bottles of 30 tablets

67877-590-60 Bottles of 60 tablets

67877-590-01 Bottles of 100 tablets

67877-590-05 Bottles of 500 tablets

67877-590-10Bottles of 1000 tablets

50 mg tablets: White to off white, round shape, biconvex film coated tablet with breakline on one side and debossed with ‘A50’ on other side. They are available as follows:

67877-591-30 Bottles of 30 tablets

67877-591-60 Bottles of 60 tablets

67877-591-01 Bottles of 100 tablets

67877-591-05 Bottles of 500 tablets

67877-591-10 Bottles of 1000 tablets

100 mg tablets: White to off white, round shape, biconvex film coated tablet with breakline on one side and debossed with ‘A100’ on other side. They are available as follows:

67877-592-30 Bottles of 30 tablets

67877-592-60 Bottles of 60 tablets

67877-592-01 Bottles of 100 tablets

67877-592-05 Bottles of 500 tablets

67877-592-10 Bottles of 1000 tablets

200 mg tablets: White to off white, oval shape, biconvex film coated tablet with breakline on one side and debossed with ‘A200’ on other side. They are available as follows:

67877-593-30 Bottles of 30 tablets

67877-593-60 Bottles of 60 tablets

67877-593-01 Bottles of 100 tablets

67877-593-05 Bottles of 500 tablets

67877-593-10 Bottles of 1000 tablets

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

17 PATIENT COUNSELING INFORMATION

Advise patients to take metoprolol succinate extended-release tablets regularly and continuously, as directed, preferably with or immediately following meals. If a dose is missed, the patient should take only the next scheduled dose (without doubling it). Patients should not interrupt or discontinue metoprolol succinate extended-release tablets without consulting the physician.

Advise patients (1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient’s response to therapy with metoprolol succinate extended-release tablets have been determined; (2) to contact the physician if any difficulty in breathing occurs; (3) to inform the physician or dentist before any type of surgery that he or she is taking metoprolol succinate extended-release tablets.

Heart failure patients should be advised to consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.

Risk of hypoglycemia
Inform patients or caregivers that there is a risk of hypoglycemia when metoprolol succinate extended-release tablets are given to patients who are fasting or who are vomiting. Instruct patients or caregivers how to monitor for signs of hypoglycemia. [see Warnings and Precautions (5.7)].

The brands listed are trademarks of their respective owners.

Manufactured by:

Alkem Laboratories Ltd.,

INDIA.

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: March, 2023

PT2937-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 67877-590-30
25mg
30 Tablets Rx Only

metoprolol-25mg-30tab
(click image for full-size original)

NDC 67877-591-30
50mg
30 Tablets
Rx Only

metoprolol-50mg-30tab
(click image for full-size original)

NDC 67877-592-30
100mg
30 Tablets
Rx Only
metoprolol-100mg-30tab
(click image for full-size original)

NDC 67877-593-01
200mg
100 Tablets Rx Only

metoprolol-200mg-100tab
(click image for full-size original)
METOPROLOL SUCCINATE metoprolol succinate er tablets tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-590
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE (METOPROLOL) METOPROLOL TARTRATE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
POVIDONE, UNSPECIFIED
ETHYLCELLULOSE (20 MPA.S)
METHYLENE CHLORIDE
TRIETHYL CITRATE
TALC
POLYETHYLENE GLYCOL 6000
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
ISOPROPYL ALCOHOL
WATER
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (off white) Score 2 pieces
Shape OVAL Size 12mm
Flavor Imprint Code A;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-590-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:67877-590-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:67877-590-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:67877-590-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:67877-590-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211143 11/27/2020
METOPROLOL SUCCINATE metoprolol succinate er tablets tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-591
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE (METOPROLOL) METOPROLOL TARTRATE 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
POVIDONE, UNSPECIFIED
ETHYLCELLULOSE (20 MPA.S)
METHYLENE CHLORIDE
TRIETHYL CITRATE
TALC
POLYETHYLENE GLYCOL 6000
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
ISOPROPYL ALCOHOL
WATER
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (off white) Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code A50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-591-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:67877-591-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:67877-591-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:67877-591-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:67877-591-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211143 11/27/2020
METOPROLOL SUCCINATE metoprolol succinate er tablets tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-592
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE (METOPROLOL) METOPROLOL TARTRATE 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
POVIDONE, UNSPECIFIED
ETHYLCELLULOSE (20 MPA.S)
METHYLENE CHLORIDE
TRIETHYL CITRATE
TALC
POLYETHYLENE GLYCOL 6000
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
ISOPROPYL ALCOHOL
WATER
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (off white) Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code A100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-592-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:67877-592-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:67877-592-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:67877-592-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:67877-592-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211143 11/27/2020
METOPROLOL SUCCINATE metoprolol succinate er tablets tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-593
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE (METOPROLOL) METOPROLOL TARTRATE 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
POVIDONE, UNSPECIFIED
ETHYLCELLULOSE (20 MPA.S)
METHYLENE CHLORIDE
TRIETHYL CITRATE
TALC
POLYETHYLENE GLYCOL 6000
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
ISOPROPYL ALCOHOL
WATER
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (off white) Score 2 pieces
Shape OVAL Size 17mm
Flavor Imprint Code A200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-593-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:67877-593-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:67877-593-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:67877-593-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:67877-593-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211143 11/27/2020
Labeler — Ascend Laboratories, LLC (141250469)
Establishment
Name Address ID/FEI Operations
Alkem Laboratories Limited 915628612 MANUFACTURE (67877-590), MANUFACTURE (67877-591), MANUFACTURE (67877-592), MANUFACTURE (67877-593)

Revised: 07/2023 Ascend Laboratories, LLC

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